Nancy E. Email & Phone Number

• Reviewing production batch and other manufacturing records to assure compliance to established procedures.• Preparing and documenting procedures, including commercial batch record preparation and review.• Review material qualification of incoming raw materials.• Reviews records to ensure that data integrity is being followed per GMP/GLP compliance.• Conducting Quality Control inspections and tests, as assigned, to support manufacturing and pharmacy operations (container/closure integrity, titration, endotoxin).• Perform work within the Quality Systems including process monitoring activities such as reviewing and documenting instrumentation output, interacting with equipment systems, laboratory record review.• Maintaining records and databases for internal departments and laboratories.• Support manufacturing and pharmacy operations, as assigned (releasing raw materials to production, label printing, production setup and final reconciliation).

Monrovia, California

• Implement, execute and report in vivo pharmacology studies focused on identifying therapeutic antibody and protein candidates in oncology, inflammation and autoimmune disease.• Responsible for sample processing, data collection and analyses (graphing, etc.), generation of draft SOPs.• Maintenance and ordering of vivarium supplies and detailed record keeping.• Work individually and in team situations in accomplishing assigned tasks, such as mammalian cell culture, basic laboratory procedures (processing serum and plasma, LAL, ELISA).• Record test results and maintain the centralized database.• Responsible for disease induction, dosing (various routes), tumor measurements, IVIS imaging, blood/tissue collection, animal husbandry and monitoring animal health.

Irvine, California

• Organize and maintain important company documents. Administer, perform and coordinate studies according to the client’s protocols and within GMP/GLP compliance.• Integrate samples and implementing quality control within the Laboratory Information Management System (LIMS).• Enter and double-enter relevant study data for client review.• Retrieve samples and SOPs through Documentum.• Prepare, perform and participate in assigned laboratory experiments that involve multiple test subjects.• Lead studies in laboratory situations to obtain critical data for researchers and scientists review.• Work individually and in team situations in accomplishing assigned tasks.• Report test results and continually maintain the centralized database.• Order supplies needed for the ophthalmology department operations, including surgical instruments and supplies.

Associate Of Science - As, Registered Veterinary Technician

Bachelor Of Arts - Ba, Art (Graphic Design)

Bachelor Of Science - Bs, Business Administration (Marketing)